Avazzia, Inc
Dallas, TX, US
AVAZZIA, INC. appears in FDA device records in Dallas, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Avazzia, Inc between 2007 and 2021. The busiest year on record is 2007, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | NFO | Substantially Equivalent | |
| K162392 | Avazzia | NUH | Substantially Equivalent | |
| K123099 | Best-AV2 Pro-Sport(tm) | GZJ | Substantially Equivalent | |
| K062641 | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 | GZJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004839404 | 3004839404 | AVAZZIA, INC. | 13140 Coit Rd Ste 515, DALLAS, TX 75240 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MDRBinder, Medical, Therapeutic
- IKDCable, Electrode
- HCCDevice, Biofeedback
- GXYElectrode, Cutaneous
- OHSLight Based Over The Counter Wrinkle Reduction
- ISAMassager, Therapeutic, Electric
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1210-2007 | Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240. | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | Terminated | ||
| Z-1209-2007 | Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240. | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | Terminated | ||
| Z-1208-2007 | Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | Terminated | ||
| Z-1207-2007 | Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain